An experimental estrogen lotion appears to reduce the number of hot flashes and other symptoms of menopause, according to results from a pivotal-stage trial of the drug Estrasorb. If approved by regulatory authorities, it would be the first estrogen replacement therapy in lotion form.
The drug's developer Novavax Inc. said that in a phase 3, 200-patient trial the lotion reduced by 80% the total number of hot flashes during the course of the 16-week trial. The study also found that about half the patients reported no hot flashes over a seven-day period after 12 weeks of treatment, compared with less than 10% of patients in the placebo group.
The trial results were presented at a meeting here of the Society for Gynecologic Investigation. The study, which enrolled women who were naturally or surgically menopausal, consisted of a three-week screening period, a one-week placebo period and a 12-week treatment period. The lotion, either active or placebo, was applied daily to each woman's thigh and calf.
Side effects of Estrasorb were similar to placebo and consistent with estrogens as a class, with the most common being endometrial disorder, breast pain, vaginal hemorrhage and infection, the Columbia, Maryland-based company said.